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Cardiomyopathies | UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic Implantable Cardiac Defibrillator Implant

Cardiomyopathies research study

What is the primary objective of this study?

The purpose of the study is to analyze the different patient profiles implanted with an Implantable Cardiac Defibrillator (ICD) in Spain (guidelines adoption) and the patient prognosis as a function of clinical profile, implant indication, arrhythmias incidence, treatments or device programming.

Who is eligible to participate?

Inclusion Criteria: - Patients with a Medtronic Implantable Cardiac Defibrillator (ICD) according to guidelines. - Patients with CareLink home Telemonitoring System. Exclusion Criteria: - Unwillingness or inability to sign study written informed consent and/or CareLink consent.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cardiomyopathies

Cardiac Arrhythmias

Cardiac Arrest

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: August 2011

Completed Date:

Phase: N/A

Type: Observational

Design:

Primary Outcome: To assess the number of ventricular and atrial arrhythmias, and atrial fibrillation burden detected by ICD.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Medtronic Bakken Research Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01561144

Discuss Arrhythmia